植入式心室辅助装置EVAHEARTⅠ治疗重症急性心力衰竭的安全性和有效性评价  

Safety and efficacy of implantable ventricular assist device EVAHEARTⅠin the treatment of advanced acute heart failure

作　　者：陈海波 王现强 杜娟 石佳 吉冰洋[1] 石丽[1] 施怡声 胡盛寿[1] Chen Haibo;Wang Xianqiang;Du Juan;Shi Jia;Ji Bingyang;Shi Li;Shi Yisheng;Hu Shengshou(Department of Cardiac Surgery,Fuwai Hospital,Chinese Academy of Medical Sciences&Peking Union Medical College(CAMS&PUMC),National Center for Cardiovascular Diseases,State Key Laboratory of Cardiovascular Disease,Beijing 100037,China)

机构地区：[1]国家心血管病中心,心血管疾病国家重点实验室,北京协和医学院,中国医学科学院阜外医院心外科,北京100037

出　　处：《中华心力衰竭和心肌病杂志（中英文）》2022年第2期106-111,共6页Chinese Journal of Heart Failure and Cardiomyopathy

基　　金：高水平医院临床科研项目(2022-GSP-QZ-7);深圳三名工程项目(SZSM201911018);深圳市医学重点学科建设项目(SZXK080)。

摘　　要：目的探讨可植入式心室辅助系统EVAHEARTⅠ治疗重症急性心力衰竭(心衰)的安全性和有效性。方法纳入2018年1月至2021年12月期间在中国医学科学院阜外医院成人外科病房接受EVAHEARTⅠ左心室辅助装置治疗的重症急性心衰患者,对EVAHEARTⅠ的安全性和有效性进行评价。安全性指标包括EVAHEARTⅠ植入前及植入后1周、1月、3月的游离血红蛋白、血红蛋白、血小板、白细胞及心肌肌钙蛋白I水平变化。有效性指标包括采用Swan-Ganz导管测量围术期(术前及术后72 h内)血流动力学指标,如平均动脉压(MAP)、心脏指数(CI)、中心静脉压(CVP)、肺动脉压(PAP)及肺毛细血管楔压(PCWP),以及术后3个月内NYHA心功能分级的变化。结果入组15例患者均为男性,年龄(43±8)岁(范围27~59岁),所有患者术前纽约心脏协会(NYHA)心功能Ⅳ级,左心室射血分数(LVEF)<25%。在EVAHERATⅠ辅助期间,泵转速1700~1950 r/min,泵流量3.95~5.0 L/min,无机械故障、停泵、泵血栓形成、电源线脱落等。植入装置后,患者游离血红蛋白波动在10~40 mg/dL之间,血小板计数及血红蛋白术后1周内下降,术后1月恢复正常水平;而白细胞计数及肌钙蛋白I术后1周内显著增加,1周后逐步降低,1月内恢复正常水平。同术前相比较,术后24 h的CI、MAP均明显增加(P均<0.05),术后48 h和72 h维持该水平。但术后24 h的PCWP、PAP及CVP均显著降低(P均<0.05)。同术前比较,15例患者左心室舒张末径(LVEDD)减小(P<0.05);LVEF增加,但差异无统计学意义(P>0.05)。15例患者术后1~3月NYHA心功能分级恢复到Ⅰ~Ⅱ级。本组15例患者均携带EVAHERTⅠ心室辅助系统出院,围术期死亡0例,术后早期因出血二次开胸1例,无感染等并发症。结论左心辅助系统EVAHEARTⅠ植入术是治疗重症急性心衰患者安全有效的外科策略之一。Objective To investigate the safety and efficacy of EVAHEARTⅠ,an implantable ventricular assist system,in the treatment of advanced acute heart failure(AHF).Methods Patients with advanced AHF who were treated with EVAHEARTⅠin Fuwai Hospital from January 2018 to December 2021 were enrolled to evaluate its safety and efficacy.The levels of free hemoglobin,hemoglobin,platelets,white blood cells and cardiac troponin I(cTnI)before and at 1 week,1 month and 3 months after EVAHEARTⅠimplantation were measured to evaluate the safety.Moreover,efficacy parameters included perioperative(preoperative and within 72h after operation)hemodynamic measures such as mean arterial pressure(MAP),cardiac index(CI),central venous pressure(CVP),pulmonary arterial pressure(PAP),and pulmonary capillary wedge pressure(PCWP)measured by Swan-Ganz catheterization,as well as changes in New York Heart Association(NYHA)functional class within 3 months after surgery.Results All the 15 patients enrolled were male,with the age of(43±8)years(range 27-59 years).All patients presented with NYHA functional classⅣand left ventricular ejection fraction(LVEF)<25%before implantation.During the operation of EVAHEARTⅠsystem,the pump speed rate ranged from 1700 r/min to 1950 r/min,the pump flow rate ranged from 3.95 L/min to 5.0 L/min,without mechanical failure,pump shutdown,pump thrombosis,or power cord loss,etc.After implantation,the patient′s free hemoglobin fluctuated between 10 mg/dL and 40 mg/dL.The platelet count and hemoglobin decreased within 1 week after operation,and returned to normal at 1 month after operation.The white blood cell count and cTnI increased significantly within 1 week after operation,gradually decreased after 1 week,and returned to normal within 1 month.Levels of CI and MAP at 24 hours after operation were significantly increased compared to those before operation(both P<0.05),and maintained during 48~72h after operation.However,the levels of PCWP,PAP and CVP at 24 hours after operation were significantly decreased(all

关 键 词：急性心力衰竭 重症 左心室辅助装置 安全性 有效性 

分 类 号：R541.6[医药卫生—心血管疾病]